A study to investigate the efficacy and safety of dupilumab therapy compared with placebo in participants aged >=18 years with moderately to severely active ulcerative colitis with an eosinophilic phenotype
- Conditions
- Colitis ulcerative
- Registration Number
- JPRN-jRCT2031220662
- Lead Sponsor
- Tanaka Tomoyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Participants must be >= 18 years of age at the time of signing the informed consent.
- Evidence of biomarker enrichment at time of screening
- Moderately to severely active UC, defined as a baseline modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopic subscore assigned during the concurrent local and central reading of the video endoscopy.
- Has a screening endoscopy with >= 2 endoscopic subscore in the Mayo score component assessment as determined by concurrent local and central reading of the video endoscopy.
- Has a baseline rectal bleeding subscore of >=1 and baseline a stool frequency score of >=1 as determined by the Mayo score component assessment.
- Participants with inadequate response/non-response, loss of response, or are intolerant of standard biologic therapy for their UC
AND/OR
Inadequate or non-responders, have shown loss of response, or are intolerant to at least 1 of the following treatments: oral corticosteroids (<=20 mg/day), 5-ASA compounds, immunomodulators, small molecules.
Participants are excluded from the study if any of the following criteria apply:
- Severe extensive colitis as evidenced by:
- - Current hospitalization
- - Likely to require surgery for the treatment of UC within 12 weeks of Screening Visit
- UC limited to the rectum only or to <20 cm of the colon.
- Presence of an ileal pouch, ostomy, stoma or fistula or history of a fistula.
- Require, or required within the 2 months before screening, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage, or other conditions possibly confounding the evaluation of benefit from study agent treatment.
- Has a prior medical history of eosinophilic colitis.
- Participants with abdominal abscess, fulminant disease, or toxic megacolon.
- Participants with intestinal failure or short bowel syndrome.
- Presence of symptomatic colonic or small bowel obstruction, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy).
- History of extensive colonic resection (eg, less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study agent on clinical disease activity.
- History of colonic mucosal dysplasia or presence of adenomatous colonic polyps not removed OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit.
- If the participant has extensive colitis for >=8 years or disease limited to left side of colon (ie, distal to splenic flexure) for >10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded.
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method